Duns Number:021228671
Device Description: Device for treatment of mild to moderate obstructive sleep apnea
Catalog Number
SILNT
Brand Name
Silent Nite
Version/Model Number
SILNT
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K183270
Product Code
LRK
Product Code Name
Device, anti-snoring
Public Device Record Key
dc5b2742-a22d-4665-b7e0-889e63c2e241
Public Version Date
October 01, 2019
Public Version Number
1
DI Record Publish Date
September 23, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 510 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2971 |
| U | Unclassified | 2 |